Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
- Conditions
- Portal HypertensionHepatic DecompensationAdvanced Chronic Liver Disease
- Registration Number
- NCT06449339
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 474
Inclusion Criteria:<br><br> - Aged 18 years of above<br><br> - Established diagnosis of chronic liver disease(s) of the following etiologies<br><br> - Alcohol-related liver disease (ARLD)<br><br> - Chronic hepatitis B (CHB)<br><br> - Chronic hepatitis C (CHC)<br><br> - Metabolic dysfunction-associated steatotic liver disease (MASLD) § Non-obese<br> (BMI <30kg/m2) and obese (BMI =30 kg/m2)<br><br> - In high-risk grey zone or CSPH, by Baveno VII criteria (for ARLD, CHB, CHC and<br> non-obese MASLD) or ANTICIPATE-NASH model (for obese MASLD) within 6 months from<br> screening<br><br> - Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD)<br><br> - LSM =25 kPa (CSPH)<br><br> - LSM =20 kPa - <25 kPa and platelet count <150 x 10^9/L; or LSM =15 kPa -<br> <20 kPa and platelet count <110 x 10^9/L (high-risk grey zone)<br><br> - ANTICIPATE-NASH model (for obese MASLD)<br><br> - Predictive probability for CSPH >90% (CSPH)<br><br> - Predictive probability for CSPH =60% - <90% (high-risk grey zone)<br><br>Exclusion Criteria:<br><br> - Presence of high-risk varices (HRV) (i.e. moderate to large oesophageal varices [OV]<br> or OV with red wale sign) found in OGD<br><br> - Current use of non-selective beta-blocker (NSBB) or any use of NSBB within 6 months<br> before<br><br> - Use of selective beta blocker, such as atenolol or metoprolol, is not excluded<br><br> - Selective beta-blocker will be switched to carvedilol in NSBB arm, and will be<br> kept unchanged in conventional arm if there is clinical need for the selective<br> beta-blocker<br><br> - Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia<br> <60/minute, hypotension with systolic blood pressure (SBP) <100 mmHg, asthma, poorly<br> controlled chronic obstructive pulmonary disease, and peripheral vascular disease)<br><br> - Current use of nitrated drugs or any use of nitrated drugs within 6 months before<br><br> o Use of sublingual nitrate, such as glyceryl trinitrate, is not excluded<br><br> - Contraindication to OGD (e.g. Intestinal perforation or obstruction)<br><br> - Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior<br> decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and<br> hepatorenal syndrome)<br><br> o Child's B cirrhosis without decompensating events is not excluded<br><br> - Current or history of hepatocellular carcinoma (HCC)<br><br> - Current or history of portal vein thrombosis<br><br> - Transjugular intrahepatic portosystemic shunt (TIPS)<br><br> - Liver transplantation<br><br> - Serious medical illness with limited life expectancy of less than 6 months<br><br> - Pregnancy<br><br> - Unable to obtain or refusal of informed consent from patient
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite of incident high-risk varices (HRV), hepatic decompensation or death
- Secondary Outcome Measures
Name Time Method Number of participants with development of each hepatic decompensation event;Number of participants with development of hepatocellular carcinoma;Change in hepatic function in terms of Child-Pugh score;Change in hepatic function in terms of model for end-stage liver disease (MELD) score;Change in liver stiffness measurement (LSM) and spleen stiffness measurement (SSM);Adverse events;Number of participants who survive until the last clinic visit